EP0416587A2

EP0416587A2 - Measuring apparatus

Info

Publication number: EP0416587A2
Application number: EP90117106A
Authority: EP
Inventors: Yoshiro C/O Terumo Kabushiki Kaisha Suzuki; Hitoshi Kikuna Haitsu 4-516 Tanaka; Noriyuki Kurihara; Yutaka Saito
Original assignee: Terumo Corp; Azbil Corp
Current assignee: Terumo Corp
Priority date: 1989-09-08
Filing date: 1990-09-05
Publication date: 1991-03-13
Also published as: US5316727A; AU635314B2; AU6214290A; EP0416587A3

Abstract

A measuring apparatus of the present invention measures the constituent concentration of a specimen after loading into the apparatus a test piece having a test material which develops coloring as a result of a reaction with the constituents of a specimen. When the apparatus detects that the test piece having the test material has been loaded, it automatically begins to measure the constituent concentration of the specimen. That is. after the loading of the test piece is detected, a predetermined time period is measured. During this time measurement, the time period is displayed at a predetermined time interval. After the time measurement of this predetermined time period is terminated, the test material is irradiated with a light, and the intensity of the light from the test material is detected. The constituent concentration of the specimen applied to the test material can be determined on the basis of the reflected light intensity thus detected. Furthermore, this measuring apparatus can detect a reverse insertion of a test piece, and is constructed so as to disable the measurement of the constituent concentration of a specimen if supplementary information to be stored along with measurement information has not been set.

Description

result of a reaction with the constituents of the specimen, comprises detection means for detecting reflected light from the test material by irradiating the test material with light; determination means for determining the constituent concentration of the . specimen on the basis of the reflected light intensity detected by the detection means; test piece detection means for detecting whether the test piece has been loaded into the apparatus's main body; judgment means for judging whether or not the intensity of the reflected light from the detection means is within a predetermined range when the loading of the test piece is detected by the test piece detection means; and notifying means for notifying that a measurement using the test piece is impossible when the reflected light intensity is judged to be out of the predetermined range by the judgment means.
Another object of the present invention is to provide a measuring apparatus which is capable of easily and accurately measuring specific constituents of a specimen only by loading a test material applied with the specimen into the measuring apparatus.
In order to achieve the above-mentioned objects, the measuring apparatus of the present invention is an apparatus which measures the constituents of a specimen on the basis of the reaction color of a test material which changes in color as a result of a reaction with the constituents of the specimen, comprises irradiation means for irradiating the test material with light; detection means for detecting light reflected from the test material of the light emitted by the irradiation means; measurement means for determining the constituent concentration of a specimen applied to the test material on the basis of a detection signal from the detection means; test piece detection means for detecting whether the test piece having the test material has been loaded into the main body of the apparatus; and control means for controlling so as to allow the measurement means to when the loading of the test piece is detected by the test piece detection means.
A further object of the present invention is to provide a measuring apparatus which is capable of easily and accurately measuring specific constituents of a specimen only by loading a test material applied with the specimen into the measuring apparatus, and which is capable of informing an operator that a measurement is being made by displaying a time period required for the measurement.
In order to achieve the above-mentioned objects, the measuring apparatus of the present invention is an apparatus which measures the constituent concentration of a specimen on the basis of the color developed by a test material after loading a test piece which includes the test material which develops color because of the constituents of a specimen, comprises detection means for detecting whether the test piece has been loaded; time measuring means for measuring a predetermined time period and displaying it at a predetermined time interval after it has been determined by the detection means that the test piece has been loaded; and measuring means for reading the degree of the coloring developed by the test material and for determining the constituent concentration of the applied specimen by photoelectrically reading out the degree of the coloring developed by the test material when the predetermined time period is measured by the time measuring means.
A still further object of the present invention is to provide a measuring apparatus which is capable of informing an operator of completion of a measurement or proximity of completion of a measurement.
A still further object of the present invention is to provide a measuring apparatus which is capable of effectively utilizing a measured constituent concentration by prohibiting the measurement when supplementary information to be stored along with the measured constituent concentration has not been set.
In order to achieve the above-mentioned objects, the measuring apparatus of the present invention is an apparatus which measures the constituent concentration of a specimen on the basis of the color developed by a test material after loading a test piece which includes the test material which develops color because of the constituents of a specimen, comprises measuring means for photoelectrically reading the degree of the coloring developed by the test material so as to measure the constituent concentration of the applied specimen when the loading of the test piece is detected; storage means for storing results of the measurement by the measuring means together with supplementary information; setting means for inputting and setting the supplementary information; and control means for controlling so as to prohibit the measuring means from measuring when supplementary information has not been input and set by the setting means.
Other features and advantages of the present invention will be apparent from the following description taken in conjunction with the accompanying drawings, in which like reference characters designate the same or similar parts throughout the figures thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is an external perspective view of the grams for the CPU 72 shown in the flowchart of Fig. 6 and various kinds of data, and a RAM 74 which is used as a work area for the CPU 72 and in which measurement results are stored along with the measurement date and time. The control sec- . tion 70 accepts, as input, the status of various kinds of connected switches in order to perform an operation corresponding to these inputs. It also obtains a blood sugar value by reading a signal value from a photosensor 30b, and displays measurement results and the contents of the memory (the RAM 74) on the liquid-crystal display section 51. Numeral 36 denotes a switch for detecting whether the test piece 1 is inserted into the opening 24. The switch is turned on when the test piece 1 is inserted, thus causing a measurement of a blood sugar value to be started automatically when the power supply of the device 50 is on.
Numeral 75 denotes an LED driver for turning on an LED 30a with a constant current when instructions are received from the control section 70. The LED 30a irradiates the test piece 1 from the rear side (the rear side of the test piece 1 shown in Fig. 1). The reflected light is detected by means of the photosensor 30b, and the blood sugar value of the blood of the test piece 1 is determined on the basis of the intensity of the reflected light. Numeral 76 denotes a signal detection circuit for converting the intensity of the reflected light, which is detected by the photosensor 30b, into a voltage value. An analog signal from the signal detection circuit 76 is input to the control section 70 and is converted from analog to digital by means of an A/D converter 81. A digital signal corresponding to the reflected light intensity is then input to the CPU 72. Numeral 77 denotes a cell as a power supply which supplies power to the whole device 50. Numeral 78 denotes a timer disposed in the control section 70, which measures the lapse of time and measures a predetermined time by the instruction from the CPU 72. Numeral 79 denotes a buzzer which generates an alarm to operators and announces lapse of one second, a measurement termination, and errors, during the count-down display which will be described later. Fig. 3 is a external perspective view illustrating the details of the insertion section of the automatic blood sugar measuring device 50 of the embodiment, into which a test piece is to be inserted. The same parts as those shown in the above-mentioned figures are given the same numerals.
Fig. 3 shows a state in which an auxiliary cover 22 is removed from the main body 50 shown in Fig. 1. The portions indicated by the dotted lines of the opening 24 and a spring 26 for urging the test piece 1 show positions of respective sections in a state in which the auxiliary body 22 is mounted. The test piece 1 inserted in the device 50 is urged toward light transmissive body 32 by a spring 26. Light L emitted from the LED (light-emitting diode) 30a irradiates the opening 2a of the test piece 1 through the light-transmissive body 32, and the reflected light reaches the photosensor 30b. This construction will be explained in detail with reference to Fig. 4.
Numeral 36 denotes a microswitch for detecting whether the test piece 1 is loaded. At the time the test piece 1 is loaded, an actuator 36a of the microswitch 36 is depressed by the side of the test piece 1, causing the microswitch to be turned on. As a result, the control section 30 accepts a signal from this switch 36, thereby detecting whether the test piece 1 has been completely loaded in the device 50. Since this actuator 36a does not turn on the switch 36 as long as the test piece 1 is not mounted normally, a defective loading of the test piece 1 can be detected by a signal from the switch 36.
Fig. 4 is a transverse sectional view of the measuring section illustrating a state taken along the line A-A of Fig. 3 in which the test piece 1 is mounted on the device 50.
Blood applied through the opening 4 of the test piece 1 oozes out in a liquid developing layer 10 and infiltrates in a reagent layer (test paper) 8. Numeral 12 denotes a liquid absorbing layer for absorbing excessive blood which is not absorbed in the liquid developing layer 10. Numeral 6 denotes a light-transmissive layer for transmitting light. Light L emitted from the LED 30a passes through the light-transmissive body 32 and the light transmissive layer 6, and indicates the test paper 8. Then, reflected light from the reagent layer (test paper) 8 reaches the photosensor 30b disposed at a position forming an angle of approximately 45⁰ with respect to the incident light. As a result, the reaction color of the test paper 8 is read out, and the blood sugar value of the blood is determined on the basis of this reaction color.
It takes approximately one minute from the time when blood is applied through the opening 4 to the time when the blood has infiltrated in the reagent layer 8 through the liquid developing layer 10 and has reacted. Hence, in this automatic blood sugar measuring device, a measurement is made one minute after the test piece 1 is inserted and loaded in the opening 24. In Fig. 4, numeral 2 denotes the main body of the test piece 1. Numeral 4a denotes a taper section formed in the opening 4 for facilitating the application of blood. Numeral 2b denotes a taper section in an opening 2a, which is formed at an angle of approximately 45°, allowing light from the LED 30a to enter.
Fig. 5 is a view illustrating the exterior of the test piece 1 in the embodiment. Fig. 5(A) is a perspective view of the front side; Fig. 5(B) is a on, the time period is counted down by one second and the remaining time period is displayed. These time periods may be measured by the timer 78 or by a control program stored in the ROM 73. When one minute has elapsed in step S13, the process proceeds to step S16 where a measurement process is performed. During this period, if it is detected in step S14 that the test piece 1 has been unloaded, the process proceeds to step S15 where an error message is displayed on the display section 51 and the buzzer 79 is turned on.
In step S16, a signal is output to the LED driver 75 to cause the LED 30a, which has been off, to emit light. In step S17, the reflected light intensity detected by the photosensor 30b is read. This reflected light intensity is output from the signal detection circuit 76, converted to a digital signal by the control section 70, and input to the CPU 72. When the reflected light intensity is thus input, the process proceeds to step S18 where the LED 30a is turned off, and the blood sugar value is determined on the basis of the reflected light intensity. The above procedure may be performed in such a way that, for example, a table including the values of reflected light intensity corresponding to the blood sugar value is previously stored in the ROM 73 or the like, and the blood sugar value may be determined by referring to the table on the basis of the input reflected light intensity.
If the blood sugar value is determined in the above way, the process proceeds to step S19 where the measurement result is displayed on the display section 51. At this time, if, for example, the measured value is smaller than a predetermined range, "Lo" is displayed on the display section 51; if greater than the predetermined range, "Hi" is displayed, thus informing an operator that the measured value is abnormal.
When the measurement process is completed, it is checked in steps S20 and S22 whether or not the storage stop switch 54 has been depressed within a predetermined time period (about 3 min.). If the switch 54 is not depressed within the predetermined time period, the process proceeds to step S23 where the measurement result is stored in the RAM 74 along with the current date and time information. If the storage stop switch 54 is depressed within the predetermined time period, the process proceeds to step S21 where the display section 51 displays that storage is stopped, and then the process returns to step S9.
As has been explained above, according to this embodiment, blood is applied to the test piece 1, and the test piece 1 is immediately loaded into the device 50, whereby the blood sugar value of the blood under measurement is measured automatically. At this time, if the test piece has been reversely inserted, an error message is displayed immediately. Therefore, an operator may once unload and correctly insert the test piece 1 again for measuring the blood sugar value.
Fig. 9 is a perspective view of an appearance of an automatic blood sugar measuring device 50a of a second embodiment of this invention. Parts common to those in Fig. 1 are given the same numerals, and an explanation thereof is omitted.
In this embodiment, a projection 4b is formed on the test piece 1. This projection 4b engages with the cutout section 24a in the opening 24 of the main body of the device 50a, thus preventing the test piece 1 from being reversely inserted.
A measurement process in the automatic blood sugar measuring device 50a equipped with a reverse insertion prevention mechanism is shown in a flowchart in Fig. 10. As is apparent from a comparison with the flowchart of Fig. 6, this measurement process is the same as the flowchart of Fig. 6 except that process steps (steps S6 through S9) for checking the reverse insertion of the test piece 1 are not included. Therefore, an explanation of the flowchart of Fig. 10 is omitted because the explanation of steps S10 through S23 of Fig. 6 previously given may be used.
Fig. 11 is a block diagram schematically illustrating the construction of the automatic blood sugar measuring device of a third embodiment. Parts common to those used in Fig. 2 are given the same numerals, and an explanation thereof is omitted.
This embodiment differs from the embodiment shown in Fig. 2 in that the buzzer driving circuit 80 is provided in the circuit. This buzzer driving circuit 80 is adapted to change, by instructed from the control section 70, a volume, a tone, and a length of sound of the buzzer 79 by means of changing a voltage or a frequency for driving the buzzer 79.
Fig. 12 is a flowchart illustrating the measurement process in the blood sugar measuring device of the third embodiment shown in Fig. 11. The control programs for performing this process are stored in the ROM 73a. In this flowchart, steps identical to the steps S of Fig. 10 are given the same step numbers, and this flowchart mainly shows steps different from the steps of the flowchart of Fig. 10.
In the flowchart of Fig. 12, in step S51, the buzzer 79 is sounded for example at a frequency A for 45 seconds. Thereafter, the frequency at which the buzzer 79 sounds is changed from frequency B (steps S53 and S54) - to frequency C (steps S55 and S56) - to frequency D (steps S57 and S58) every five seconds. When the measurement is terminated finally, the buzzer 79 is sounded at a frequency E in step S59. These A to E are not limited to frequencies. For example, they may correspond to the length or mined as described above, the process proceeds to step S78 where it is checked whether or not the measurement result is greater than an allowable maximum value. If the result is smaller than the allowable maximum value, the process proceeds to . step S79 where the result is compared with an allowable minimum value. If the measurement result is between the allowable maximum value and the allowable minimum value, the process proceeds to step S81 where the measurement result is displayed on the display section 51. At this time, if the measured value is smaller than the allowable minimum value, "Lo" is displayed on the display section 51 in step S86; if greater than the allowable maximum value, "Hi" is displayed in step S95, thus notifying an operator that the measured value is abnormal.
Next, in steps S81 and S82, it is determined whether or not the storage stop switch 54 described above has been depressed within a predetermined time period (about 3 min ). If the switch 54 is not depressed within the predetermined time period, the process proceeds to step S84 where the measurement result is stored in the RAM 74 along with the current date and time information. If the storage stop switch 54 is depressed within the predetermined time period in step S81, the process proceeds to step S83 where the display section 51 indicates that storage is stopped, and then the process returns to step S64.
Fig. 15 is a flowchart illustrating the date and time setting process of step S63 of Fig. 14.
In step S91, the system waits for the setting switch 55 to be depressed. If it is depressed, the process proceeds to step S92 for updating month data, in which month data is blinked on and off, and month data is increased by 1 each time the change switch 56 is depressed. When desired month data to be input is displayed, the setting switch 55 is depressed. To thereby store the month data which is currently displayed on the display section 51 as month information in the RAM 74.
Hereinafter, in the same way as the above, when the setting switch 55 is turned on in step S93, day data is blinked on and off. In step S94, day data set by the change switch 56 is stored by the setting switch 55. Similarly, hour data is set and stored in steps S95 and S96, and minute data is set and stored in steps S97 and S98. When month, day, and hour data are stored in this manner, the date and time setting flag 74a is set in step S99.
Though not particularly shown in this embodiment, the name, sex, age, body temperature, blood pressure, etc. of a person under inspection can be entered and set by utilizing alphanumeric keys or numeric keys.
The date and time data thus set is constantly updated according to the information from the timer 78. When the blood sugar value is measured, the result of the measurement is stored in the memory (the RAM 74) together with the date and time data. Whenever the storage retrieval switch is depressed, the measurement result can be read out and displayed on the display section 51 along with the stored date and time data.
As has been explained above, according to this embodiment, when the date and time information, indispensable in storing and referring to the measurement results of the blood sugar values, has not been stored, the blood sugar value measurement process is automatically prohibited, thus effectively utilizing the measured blood sugar value information without rendering it useless. In this embodiment, the supplement information has been explained as the data of date and time, but this invention is not limited to this embodiment. For example, the supplement information would be a name of person under inspection (if enable to input the name) and the other identifiable information.
In this embodiment, a blood sugar measurement has been explained by way of example. However, the present invention is not limited to this device. It can be applied to, for instance, an analysis device for uric acids, GTO, GPT, cholesterol, or the like. Regarding a specimen, for example, body fluids such as urine and saliva may be considered in addition to blood.
As many widely different embodiments of the present invention can be made without departing from the spirit and scope thereof, it is to be understood that the invention is not limited to the specific embodiments thereof except as defined in the appended claims.

Claims

1. A measuring apparatus which measures the constituent concentration of a specimen after loading a test piece having a test material which develops coloring as a result of a reaction with the constituents of said specimen, comprising:

detection means for detecting a reflected light from said test material by irradiating said test material with light;

determination means for determining the constituent concentration of said specimen on the basis of the reflected light intensity detected by said detection means;

test piece detection means for detecting that said test piece has been loaded into the apparatus's main body;

judgment means for judging whether or not the intensity of the reflected light from said detection means is within a predetermined range when the period in seconds, and said measuring apparatus further comprising a notifying means for generating a sound every second.

13. The measuring apparatus as claimed in claim 12, wherein at least one of the volume, tone and. length of the sound generated by said notifying means is changed when a remaining time period with respect to said predetermined time period falls below predetermined value during the time measurement by said time measurement means.

14. A measuring apparatus which measures the constituent concentration of a specimen on the basis of the color developed by a test material after loading a test piece which includes the test material which develops color because of the constituents of a specimen, comprising:

measurement means for photoelectrically reading the degree of the coloring developed by said test material and measuring the constituent concentration of said applied specimen when the loading of said test piece is detected;

storage means for storing measured results by said measurement means together with supplementary information;

setting means for inputting and setting said supplementary information; and

control means for controlling so as to prohibit the said measurement means from measuring when supplementary information has not been input and set by said setting means.

15. The measuring apparatus as claimed in claim 14, wherein said supplementary information includes at least date and time information.

16. The measuring apparatus as claimed in claim 15, further comprising a time measurement means and an update means for updating the date and time information of said supplementary information on the basis of the information from said time measurement means.

17. A measuring apparatus which measures the constituent concentration of a specimen on the basis of the color developed by a test material after loading a test piece which includes the test material which develops color because of the constituents of a specimen, comprising:

storage means for storing measured constituent concentration together with supplementary information;

setting means for inputting and setting said supplementary information;

detection means for detecting whether said test piece has been loaded;

determination means for determining whether or not said supplementary information has been set after it is detected by said detection means that said test piece has been loaded;

time measurement means for measuring a predetermined time period when it is determined by

said determination means that said supplementary information has been set;

display means for displaying a time period at a predetermined time interval during the time measurement by said time measurement means;

irradiation means for irradiating said test material after the time measurement by said time measurement means is terminated;

detection means for detecting the reflected light intensity from said test material irradiated by said irradiation means; and

measurement means for determining the concentration of the constituents of said specimen applied to said test material on the basis of the reflected light intensity detected by said detection means.

18. The measuring apparatus as claimed in claim 17, wherein said supplementary information includes date and time information at the least.

19. The measuring apparatus as claimed in claim 17, wherein said predetermined time period corresponds to a time period necessary to change color of said test material as a result of a reaction with said specimen.